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Abstract:

A treatment instrument for medical use includes: an outer tube having a
flexible tube at a distal portion thereof; an image information
acquisition unit disposed inside the outer tube and configured to be
inserted into and drawn out of the flexible tube; and a fluid conveying
tube which is disposed inside the outer tube juxtaposedly with the image
information acquisition unit and is insertable into and drawn out of the
flexible tube in a selective manner in relation to the image information
acquisition unit. The outer tube is greater than the flexible tube in
diameter and is decreased in diameter, at a connection part for
connection with the flexible tube, down to the diameter of the flexible
tube.

Claims:

1. A treatment instrument for medical use comprising: an outer tube
possessing an outer diameter; a flexible tube possessing a proximal end
connected to a distal end of the outer tube by a connection portion, the
flexible tube possessing an outer diameter; an image information
acquisition unit disposed inside the outer tube and configured to be
inserted into and drawn out of the flexible tube; a fluid conveying tube
disposed inside the outer tube in juxtaposed relation to the image
information acquisition unit and configured to be inserted into and drawn
out of the flexible tube in a selective manner relative to the image
information acquisition unit; and the outer diameter of the outer tube at
the distal end of the outer tube being greater than the outer diameter of
the entire flexible tube, and the connection part being configured to
possess a decreasing outer diameter that decreases from the distal end of
the outer tube to the proximal end of the flexible tube.

2. The treatment instrument for medical use according to claim 1, further
comprising, inside the outer tube: a first guide tube in which the image
information acquisition unit is positioned in a manner permitting
advancing and retracting movement of the image information acquisition
unit and by which the image information acquisition unit is guided into
the flexible tube; and a second guide tube in which the fluid conveying
tube is positioned in a manner permitting advancing and retracting
movement of the fluid conveying tube and by which the fluid conveying
tube is guided into the flexible tube.

3. The treatment instrument for medical use according to claim 2, wherein
the first guide tube and the second guide tube axially overlap a portion
of the outer tube located proximal to the connection part and extend up
to connection part between the outer tube and the flexible tube.

4. The treatment instrument for medical use according to claim 1, further
comprising position fixing means for fixing advanced/retracted positions
of the image information acquisition unit and the fluid conveying tube.

5. The treatment instrument for medical use according to claim 1, further
comprising an inflation body disposed around an outer circumference of
the flexible tube and inflatable in a radial direction of the flexible
tube.

6. The treatment instrument for medical use according to claim 1, wherein
the image information acquisition unit includes a biasing member
configured to bias the image information acquisition unit in a curving
direction.

7. A treatment instrument for medical use comprising: an outer tube
having a flexible tube at a distal portion of the outer tube; an image
information acquisition unit disposed inside the outer tube and movable
relative to the outer tube and the flexible tube to insert the image
information acquisition unit into the flexible tube and to draw out the
image information acquisition unit from the flexible tube; an inflation
body disposed around an outer circumferential surface of the flexible
tube and inflatable in a radial outward direction of the flexible tube;
and the image information acquisition unit including a biasing member
configured to bias the image information acquisition unit in a curving
direction.

8. The treatment instrument for medical use according to claim 7, further
comprising a guide tube positioned in the outer tube, the image
information acquisition unit being positioned in the guide tube so that
the guide tube restricts variations in shape of the image information
acquisition unit and guides the image information acquisition unit into
the flexible tube.

9. The treatment instrument for medical use according to claim 8, further
comprising a fluid conveying tube disposed inside the outer tube in
side-by-side relation to the image information acquisition unit and
movable relative to the flexible tube and the outer tube so that the
fluid conveying tube is insertable into and movable out of the flexible
tube in a selective manner relative to the image information acquisition
unit.

10. The treatment instrument for medical use according to claim 9,
wherein the guide tube is one guide tube, and further comprising another
guide tube located inside the outer tube and in which is movably
positioned the fluid conveying tube.

11. The treatment instrument for medical use according to claim 7,
further comprising a fluid conveying tube inside the outer tube and
positioned in side-by-side relation to the image information acquisition
unit, the fluid conveying tube being movable relative to the flexible
tube and the outer tube so that the fluid conveying tube is insertable
into and movable out of the flexible tube in a selective manner relative
to the image information acquisition unit.

12. A method of observing the inside of a paranasal sinus comprising:
inserting a flexible tube into the paranasal sinus through a nasal
cavity; inserting an image information acquisition unit in the inserted
flexible tube and moving the image information acquisition unit in a
distal direction relative to the flexible tube to position the image
information acquisition unit in the paranasal sinus; and checking a state
inside the paranasal sinus based on image information about the inside of
the paranasal sinus acquired by the image information acquisition unit
positioned inside the paranasal sinus.

13. The method of observing the inside of a paranasal sinus according to
claim 12, further comprising a biasing member that causes the image
information acquisition unit to curve, and wherein the moving of the
image information acquisition unit in the distal direction relative to
the flexible tube includes moving the image information acquisition unit
in the distal direction relative to the flexible tube until a distal
portion of the image information acquisition unit is positioned distally
beyond a distal end of the flexible tube, the biasing member causing the
distal portion of the image information acquisition unit positioned
distally beyond the distal end of the flexible tube to curve.

14. The method of observing the inside of a paranasal sinus according to
claim 12, further comprising checking a position of the image information
acquisition unit inside the paranasal sinus based on the image
information about the inside of the paranasal sinus acquired by the image
information acquisition unit positioned inside the paranasal sinus.

15. A method of dilating a stenosed part of a paranasal sinus natural
ostium comprising: inserting a flexible tube through a nasal cavity and
into a paranasal sinus in which is located a stenosed part, the flexible
tube including an inflatable body; inserting an image information
acquisition unit into the flexible tube positioned in the paranasal
sinus; moving the image information acquisition unit in a distal
direction relative to the flexible tube so that a distal portion of the
image information acquisition unit extends distally beyond a distal end
of the flexible tube and so that the distal portion of the image
information acquisition unit bends; acquiring image information about the
stenosed part in the paranasal sinus by operation of the image
information acquisition unit; checking a state of the stenosed part in
the paranasal sinus based on the image information acquired by the image
information acquisition unit; and inflating the inflation body based on a
result of the checking.

16. The method of dilating the stenosed part of the paranasal sinus
natural ostium according to claim 15, further comprising checking a
position of the inflation body in the paranasal sinus based on the image
information acquired by the image information acquisition unit.

17. The method of dilating the stenosed part of the paranasal sinus
natural ostium according to claim 15, wherein the distal portion of the
image information acquisition unit bends automatically by virtue of a
biasing force applied to the distal portion of the image information
acquisition unit.

18. The method of dilating the stenosed part of the paranasal sinus
natural ostium according to claim 15, further comprising acquiring
additional image information about the stenosed part in the paranasal
sinus after inflating the inflation body, and further comprising
determining whether or not the stenosed part has been dilated based on
the additional acquired image information.

19. A method of treating sinusitis comprising: inserting a flexible tube
into a paranasal sinus natural ostium through a nasal cavity; moving an
image information acquisition unit inside the inserted flexible tube to
advance the image information acquisition unit in a distal direction
within the flexible tube and position the image information acquisition
unit in the paranasal sinus; checking a state inside the paranasal sinus
based on image information on the inside of the paranasal sinus acquired
by the inserted image information acquisition unit; drawing the image
information acquisition unit out of the flexible tube; moving a fluid
conveying tube in the flexible tube to advance the fluid conveying tube
in a distal direction within the flexible tube; and withdrawing a fluid
present inside the paranasal sinus to outside by way of the fluid
conveying tube positioned in the flexible tube or introducing a fluid
from the outside into the paranasal sinus by way of the fluid conveying
tube positioned in the flexible tube.

20. A method of treating sinusitis according to claim 19, wherein the
moving of the image information acquisition unit inside the inserted
flexible tube to advance the image information acquisition unit in the
distal direction within the flexible tube and position the image
information acquisition unit in the paranasal sinus also comprises
bending a distal portion of the image information acquisition unit when
the distal portion of the image information acquisition unit is located
in the paranasal sinus.

Description:

[0001] This application is based on and claims priority to U.S.
Provisional Application No. 61/635,587 filed on Apr. 19, 2012, the entire
content of which is incorporated herein by reference.

TECHNOLOGICAL FIELD

[0002] The present invention generally relates to a treatment instrument
for medical use capable of dilating a natural ostium stenosed due to
sinusitis, a method of observing the inside of a paranasal sinus, a
method of dilating a stenosed part of a paranasal sinus natural ostium,
and a method of treating sinusitis.

BACKGROUND DISCUSSION

[0003] Inflammation generated in a nasal cavity due to common cold,
allergy or the like may spread to a paranasal sinus, which is an
intraosseous cavity adjacent to the nasal cavity. The inflammation
generated in the paranasal sinus in this manner is called sinusitis. The
paranasal sinus communicates with the nasal cavity through a tiny hole
called the natural ostium. When edema, hypertrophy or the like of mucous
membrane is generated in the vicinity of the natural ostium due to
sinusitis, the natural ostium is stenosed. This makes it difficult for
secretion, bacteria and the like in the paranasal sinus to be discharged
to the nasal cavity, and causes ventilation disorder.

[0004] As a treatment of sinusitis, conventionally, there has commonly
been practiced a surgical treatment in which the stenosed part of the
natural ostium is removed by use of forceps, a drill or the like. In
recent years, on the other hand, attention has been directed at a
minimally invasive treatment in which the narrowed natural ostium is
dilated by a balloon catheter. An example is disclosed in Japanese
Application No. T-2008-513125.

[0005] Japanese Application No. T-2008-513125 describes that the natural
ostium is dilated by operating a balloon catheter under endoscopic
observation.

SUMMARY

[0006] When a balloon catheter is operated endoscopically, it can be
difficult to relatively easily and accurately carry out the treatment,
since an operator's hands are full or the visible region is limited by
the thickness (radial size) of the endoscope. In consideration of these
problems, the present inventors have been researching and developing
balloon catheters on which a miniaturized camera is mounted.

[0007] Here, in the case of mounting a camera on a balloon catheter, it is
a common practice to dispose the camera at a distal end of the catheter
and to check the forward (distal) side of the balloon, for the purpose of
searching for the natural ostium. When the camera is fixedly disposed at
the distal end of the catheter, however, a space for adding other
functions to the distal portion of the catheter has to be secured
separately. This makes the distal portion greater in diameter, thereby
making it difficult to insert the balloon catheter into a living body.

[0009] The method for checking the state inside a paranasal sinus and for
performing therapy of sinusitis disclosed here can be performed without
any surgical procedure.

[0010] A treatment instrument for medical use includes an outer tube
possessing an outer diameter, a flexible tube possessing a proximal end
connected to a distal end of the outer tube by a connection portion, with
the flexible tube possessing an outer diameter; an image information
acquisition unit disposed inside the outer tube and configured to be
inserted into and drawn out of the flexible tube; a fluid conveying tube
disposed inside the outer tube in juxtaposed relation to the image
information acquisition unit and configured to be inserted into and drawn
out of the flexible tube in a selective manner relative to the image
information acquisition unit; and the outer diameter of the outer tube at
the distal end of the outer tube being greater than the outer diameter of
the entire flexible tube, and the connection part being configured to
possess a decreasing outer diameter that decreases from the distal end of
the outer tube to the proximal end of the flexible tube.

[0011] The image information acquisition unit and the fluid conveying tube
are accommodated in the outer tube of the treatment instrument for
medical use. Therefore, the image information acquisition unit and the
fluid conveying tube can be used while holding the treatment instrument
for medical use in one hand. Consequently, easiness and accuracy of the
treatment can be enhanced.

[0012] In addition, since the flexible tube is disposed at the distal
portion of the outer tube, the treatment instrument for medical use can
be inserted into a living body while curving the flexible tube. In
addition, since the connection part for connection between the outer tube
and the flexible tube is decreased in diameter down to the diameter of
the flexible tube, the distal portion of the outer tube can be made small
in diameter. Therefore, the flexible tube can be relatively easily
inserted into a passage of a stenosed part generated in a natural ostium
of a paranasal sinus. Since the image information acquisition unit and
the fluid conveying tube can be selectively inserted into and drawn out
of the flexible tube inserted in the stenosed part, the treatment
instrument for medical use can be easily inserted into the paranasal
sinus.

[0013] The treatment instrument for medical use preferably includes,
inside the outer tube: a first guide tube in which the image information
acquisition unit is held in an advanceable and retractable manner and by
which the image information acquisition unit is guided into the flexible
tube; and a second guide tube in which the fluid conveying tube is held
in an advanceable and retractable manner and by which the fluid conveying
tube is guided into the flexible tube.

[0014] The first guide tube for guiding the image information acquisition
unit into the flexible tube and the second guide tube for guiding the
fluid conveying tube into the flexible tube are disposed inside the outer
tube. This helps ensure that the image information acquisition unit and
the fluid conveying tube can be prevented from interfering with each
other within the outer tube or being caught on the outer tube. Therefore,
the image information acquisition unit and the fluid conveying tube can
be rather assuredly guided into the flexible tube.

[0015] The treatment instrument for medical use disclosed here is
preferably configured so that the first guide tube and the second guide
tube extend up to the connection part between the outer tube and the
flexible tube.

[0016] By virtue of the first and second guide tubes extending inside the
outer tube up to the connection part between the outer tube and the
flexible tube, the image information acquisition unit and the fluid
conveying tube can be guided into the vicinity of the flexible tube by
the first and second guide tubes. The connection part between the outer
tube and the flexible tube is decreased in diameter down to the diameter
of the flexible tube. This helps ensure that the image information
acquisition unit and the fluid conveying tube can be smoothly guided
along an inner surface of the connection part into the flexible tube.
Therefore, image information acquisition unit and the fluid conveying
tube can be more assuredly guided into the flexible tube.

[0017] The treatment instrument for medical use preferably includes
position fixing means for fixing advanced/retracted positions of the
image information acquisition unit and the fluid conveying tube.

[0018] The advanced/retracted positions of the image information
acquisition unit and the fluid conveying tube can be fixed by the
position fixing means. This makes it unnecessary for an operator to
continue holding the image information acquisition unit or the fluid
conveying tube. Consequently, the burden on the operator can be
alleviated, and the operator is permitted to concentrate on diagnosis or
therapy of a patient.

[0019] The treatment instrument for medical use preferably also includes
an inflation body disposed around the outer circumference of the flexible
tube and inflatable in a radial direction of the flexible tube.

[0020] The inflation body can be inflated in the stenosed part generated
in the natural ostium of the paranasal sinus. Therefore, the stenosed
part can be dilated and cured.

[0021] The image information acquisition unit preferably includes a
biasing member configured to bias the image information acquisition unit
in a curving direction.

[0022] The image information acquisition unit can thus be biased in the
curving direction by the biasing member. This helps ensure that at the
time of checking the inserted position of the flexible tube in the living
body, there is no need for an operation of curving the image information
acquisition unit, passed through the flexible tube, toward the flexible
tube side. Consequently, the burden on the operator can be more
alleviated.

[0023] According to another aspect, a treatment instrument for medical use
includes an outer tube having a flexible tube at a distal portion of the
outer tube, an image information acquisition unit disposed inside the
outer tube and movable relative to the outer tube and the flexible tube
to insert the image information acquisition unit into the flexible tube
and to draw out the image information acquisition unit from the flexible
tube, and an inflation body disposed around an outer circumferential
surface of the flexible tube and inflatable in a radial outward direction
of the flexible tube, and wherein the image information acquisition unit
includes a biasing member configured to bias the image information
acquisition unit in a curving direction.

[0024] The image information acquisition unit can be biased in the curving
direction by the biasing member. This helps ensure that at the time of
checking an inflated state of the inflation body in a living body, there
is no need for an operation of curving the image information acquisition
unit, passed through the flexible tube, toward the inflation body side.
Therefore, the burden on the operator can be reduced.

[0025] The treatment instrument for medical use preferably includes,
inside the outer tube, a guide tube configured to restrict variations in
shape of the image information acquisition unit therein and to guide the
image information acquisition unit into the flexible tube. This makes it
possible to prevent the image information acquisition unit from being
deformed and caught on the outer tube. Consequently, the image
information acquisition unit can be assuredly guided into the flexible
tube.

[0026] Another aspect involves a method of observing the inside of a
paranasal sinus. The method includes inserting a flexible tube into the
paranasal sinus through a nasal cavity, inserting an image information
acquisition unit in the inserted flexible tube and moving the image
information acquisition unit in a distal direction relative to the
flexible tube to position the image information acquisition unit in the
paranasal sinus, and checking a state inside the paranasal sinus based on
image information about the inside of the paranasal sinus acquired by the
image information acquisition unit positioned inside the paranasal sinus.

[0027] It is possible, in observing the inside of the paranasal sinus, to
deform the flexible tube following up to the shape of the natural ostium
of the paranasal sinus. This enables a working member such as the image
information acquisition unit and the fluid conveying tube to be easily
inserted into the paranasal sinus. Furthermore, the need for preparing in
advance a plurality of treatment instruments or a rigid endoscope or the
like as in the related art is eliminated. Therefore, the number of
treatment instruments required for therapy of sinusitis can be reduced,
and the effort and time required for exchange of the treatment instrument
can be reduced.

[0028] In addition, since the image information acquisition unit is
inserted and passed in the inserted flexible tube, the state inside the
paranasal sinus can be checked without any surgical procedure.

[0029] A method of dilating a stenosed part of a paranasal sinus natural
ostium according to the present invention involves inserting a flexible
tube through a nasal cavity and into a paranasal sinus in which is
located a stenosed part, the flexible tube including an inflatable body,
inserting an image information acquisition unit into the flexible tube
positioned in the paranasal sinus, moving the image information
acquisition unit in a distal direction relative to the flexible tube so
that a distal portion of the image information acquisition unit extends
distally beyond a distal end of the flexible tube and so that the distal
portion of the image information acquisition unit bends, acquiring image
information about the stenosed part in the paranasal sinus by operation
of the image information acquisition unit, checking a state of the
stenosed part in the paranasal sinus based on the image information
acquired by the image information acquisition unit, and inflating the
inflation body based on a result of the checking.

[0030] The inflation body can be inflated after checking the position of
the inflation body in the stenosed part on the basis of the image
information supplied from the image information acquisition unit inserted
in the paranasal sinus, and so the inflation body can be inflated at an
appropriate position inside the stenosed part. Consequently, dilation and
curing of the stenosed part can be carried out effectively.

[0031] The method preferably also includes acquiring image information on
the stenosed part after inflating the inflation body, and determining
whether or not the stenosed part has been dilated on the basis of the
acquired image information.

[0032] Whether or not the stenosed part has been dilated is determined on
the basis of the acquired image information. This makes it possible to
visually inspect that the stenosed part has been dilated. Therefore, it
can be assuredly confirmed that the stenosed part has been dilated, and
the therapeutic result can be shown to a patient through an image.

[0033] A method of treating sinusitis comprises inserting a flexible tube
into a paranasal sinus natural ostium through a nasal cavity, moving an
image information acquisition unit inside the inserted flexible tube to
advance the image information acquisition unit in a distal direction
within the flexible tube and position the image information acquisition
unit in the paranasal sinus, checking a state inside the paranasal sinus
based on image information on the inside of the paranasal sinus acquired
by the inserted image information acquisition unit, drawing the image
information acquisition unit out of the flexible tube, moving a fluid
conveying tube in the flexible tube to advance the fluid conveying tube
in a distal direction within the flexible tube, and withdrawing a fluid
present inside the paranasal sinus to outside by way of the fluid
conveying tube positioned in the flexible tube or introducing a fluid
from the outside into the paranasal sinus by way of the fluid conveying
tube positioned in the flexible tube.

[0034] In conveying a fluid into or out of the paranasal sinus, the state
inside the paranasal sinus can be checked on the basis of the acquired
image information on the inside of the paranasal sinus. Therefore, it is
possible to carry out an effective therapy according to the state inside
the paranasal sinus.

BRIEF DESCRIPTION OF THE DRAWINGS

[0035] FIG. 1 is a lateral view showing, partly in cross-section, a
treatment instrument for medical use according to one embodiment
disclosed by way of example here.

[0036] FIGS. 2A and 2B are views, partly in cross-section, illustrating a
grip section of the treatment instrument for medical use.

[0037]FIG. 3 is a cross-sectional view of an image information
acquisition unit accommodated in the treatment instrument for medical
use.

[0038] FIGS. 4A and 4B are views which illustrate the shape of a distal
portion of a biasing member disposed in the image information acquisition
unit.

[0039]FIG. 5A is an illustration of a state in use of the treatment
instrument for medical use.

[0040]FIG. 5B is an illustration of a state in use of the treatment
instrument for medical use.

[0041]FIG. 5c is an illustration of a state in use of the treatment
instrument for medical use.

[0042]FIG. 5D is an illustration of a state in use of the treatment
instrument for medical use.

[0043]FIG. 5E is an illustration of a state in use of the treatment
instrument for medical use.

[0044]FIG. 5F is an illustration of a state in use of the treatment
instrument for medical use.

DETAILED DESCRIPTION

[0045] As shown in FIGS. 1, 2A and 2B, a treatment instrument 10 for
medical use according to one embodiment, representing an example of the
medical use treatment instrument disclosed here, includes an introduction
section 1 (FIG. 1) to be introduced into a living body, and a grip
section 9 (FIGS. 2A and 2B) disposed on the proximal side of the
introduction section 1.

[0046] In FIG. 1, the introduction section 1 includes: an outer tube 3, a
flexible tube 2 at a distal portion of the outer tube 3; an endoscope 4
as an image information acquisition unit disposed inside the outer tube 3
and configured to be inserted into and drawn out of the flexible tube 2;
a suction tube 5 as a fluid conveying tube disposed inside the outer tube
3 juxtaposedly (in side-by-side relation) with the endoscope 4 and
configured to be inserted into and drawn out of the flexible tube 2 in a
selective manner in relation to the endoscope 4; a first guide tube 6 as
a guide tube configured to guide the endoscope 4 into the flexible tube
2; a second guide tube 7 configured to guide the suction tube 5 into the
flexible tube 2; and an inflation body 8 disposed around an outer
circumference of the flexible tube 2 and configured to inflate in the
radial direction of the flexible tube 2.

[0047] The flexible tube 2 includes a plurality of tubular elements 21,
22, 23, 24, which are turnable relative to one another and are connected
to one another in an axial direction. That is, the tubular elements are
turnable relative to one another so that the distal end of the flexible
tube can be bent such as in the manner shown in FIG. 5A. Operating means
such as a wire is connected to the tubular element 21 on the distal side
(distal end) of the flexible tube 2. The flexible tube 2 can be curved,
and the curved position of the flexible tube 2 can be fixed, by the
operating means. In addition, the outer circumference of the flexible
tube 2 is covered, in close contact, by a flexible tubular member 25 such
as an elastic member, so that a fluid being fed to the inflation body 8
will not flow into the inside of the flexible tube 2 through gaps between
the tubular elements 21 to 24.

[0048] The tubular element 21 on the distal side and the tubular element
22 on the proximal side have turning shaft sections 211 and 221,
respectively, projecting in a connecting direction (the axial direction
of each of the tubular elements 21 and 22) from an end edge on one side
in the connecting direction. Between the tubular element 21 on the distal
side and the tubular element 22 on the proximal side, the tubular
elements 23 and 24 having different shapes are alternately arranged.

[0049] The tubular element 23 has turning shaft sections 231 projecting in
the connecting direction (the axial direction of the tubular element 23)
from end edges on both sides (proximal and distal sides/ends) in the
connecting direction.

[0050] On the other hand, the tubular element 24 has turning support
sections 241 where end edges on both sides (proximal and distal
sides/ends) in the connecting direction (the axial direction of the
tubular element 24) are recessed. The turning shaft sections 211, 221 and
231 of the tubular elements 21 to 23 are supported by the turning support
sections 241.

[0051] The turning shaft sections 211, 221 and 231 and the turning support
sections 241 are disposed in pairs at positions symmetric about center
axes of the tubular elements 21 to 24, respectively.

[0052] The outer tube 3 includes a tubular accommodation section 31 in
which the guide tubes 6 and 7 are accommodated, and a conical
decreasing-diameter section 32 which constitutes a connection part
between the accommodation section 31 (distal end of the outer tube 31)
and the flexible tube 2 (proximal end of the flexible tube 2) and which
decreases in diameter (both inner and outer diameters in the illustrated
embodiment) from the diameter of the accommodation section 31 to the
diameter of the flexible tube 2.

[0053] The flexible tube 2 and the outer tube 3 as above-mentioned are
obtained, for example, by a method in which a portion on the distal side
relative to the decreasing-diameter section 32, of a stainless steel-made
hollow cylindrical member having the decreasing-diameter section 32, is
subjected to laser beam processing. Where laser beam processing is used,
the introduction section 1 in the state in which the tubular elements 21
to 24 of the flexible tube 2 are connected with one another can be
relatively easily obtained by simply cutting the hollow cylindrical
member by use of a laser beam.

[0054] As shown in FIG. 3 also, the endoscope 4 includes: a biasing member
41 for biasing the endoscope 4 in a curving direction; an image sensing
unit 42 having an image sensing device such as a CCD (Charge Coupled
Device) image sensor; a light transmission section 43 such as an optical
fiber for transmitting light toward a distal portion of the endoscope 4;
and an outer cylinder 44 for accommodating these components 41 to 43. The
endoscope 4 is so configured that it can be cured by operating means such
as a wire connected to a distal portion of the endoscope. The image
sensing unit 42 is not restricted to the image sensing unit described
above. For example, it may be a digital video camera using other image
sensing device such as a CMOS (Complementary Metal-Oxide Semiconductor)
image sensor, an image fiber for acquisition and transmission of an image
by utilizing optical fiber, or an image sensing system for transmission
of an image by an optical system including an objective lens and a
plurality of relay lenses.

[0055] The biasing member 41 is formed from a superelastic alloy such as
nickel-titanium alloys, or from a shape memory alloys, and has a
previously reshaped curved portion which turns back toward the proximal
side in a condition where no external force is exerted on the biasing
member. In other words, when no force is applied to the biasing member,
the biasing member will bend or curve. As shown in FIG. 4A and FIG. 4B, a
distal portion 411 of the biasing member 41 is formed in the shape of a
thin sheet which is thinned relative to the proximal side in lateral view
and which is broadened relative to the proximal side in plan view. With
the distal portion 411 formed in such a shape, the distal portion 411 can
be inhibited or prevented from damaging the outer cylinder 44.

[0056] The suction tube 5 is a pipeline for sucking solid matter, fluid or
the like present in a living body, and is connected to a suction device
such as a suction pump.

[0057] The first and second guide tubes 6 and 7 are accommodated in the
accommodation section 31 of the outer tube 3, and extend up to the
decreasing-diameter section 32 of the outer tube 3. That is, the first
and second guide tubes 6 and 7 axially overlap a portion of the outer
tube located proximal of the decreasing-diameter section 32 (connection
part) of the outer tube 3, and extend up to a location at which the
distal end of the outer tube 3 is connected to the decreasing-diameter
section 32 (connection part) of the outer tube 3.

[0058] The endoscope 4 is held in the first guide tube 6 in an advanceable
and retractable manner, and in the first guide tube 6 guides the
endoscope 4 into the flexible tube 2 while restricting the variation in
shape of the endoscope 4 by the biasing member 41.

[0059] The suction tube 5 is held in the second guide tube 7 in an
advanceable and retractable manner.

[0060] The inflation body 8 is formed from a flexible material such as a
polymer. The inside of the inflation body 8 communicates with a channel
81 disposed around the outer tube 3, and is so configured that the
inflation body 8 is radially inflated when a fluid is introduced into the
inflation body 8 through the channel 81.

[0061] As shown in FIG. 2A and FIG. 2B, the grip section 9 includes: a
first operating section 91 (representing an example of position fixing
means for fixing the position of the endoscope 4) by which the endoscope
4 is inserted into and drawn out of the flexible tube 2 and by which the
advanced/retracted position of the endoscope 4 is fixed; a second
operating section 92 (representing an example of position fixing means
for fixing the position of the suction tube 5) by which the suction tube
5 is inserted into and drawn out of the flexible tube 2 and by which the
advanced/retracted position of the suction tube 5 is fixed; and a third
operating section 93 by which the inflation body 8 is inflated or
contracted and by which the inflated state of the inflation body 8 is
maintained.

[0062] The first operating section 91 and the second operating section 92
hold the endoscope 4 and the suction tube 5 respectively inside the grip
section 9. These operating sections 91 and 92 are slidable toward the
outer tube 3, and can each be fixed at a position indicated by solid line
in FIG. 2A and a position indicated by alternate long and short dash line
in FIG. 2A. Specifically, when each of the operating sections 91 and 92
is located in the position of solid line, the endoscope 4 or the suction
tube 5 is inserted and located in the flexible tube 2, whereas when each
of the operating sections 91 and 92 is located in the position of
alternate long and short dash line, the endoscope 4 or the suction tube 5
is drawn out or located outside of the flexible tube 2.

[0063] The third operating section 93 is so disposed that it can be
advanced into and retracted from a fluid introduction passage 94
communicating with the channel 81 for the inflation body 8. With the
third operating section 93 advanced or retracted, the inflation body 8 is
inflated or contracted. Specifically, the third operating section 93
includes: a rod 96 screw engaged with a threaded hole formed in a plug
member 95 for plugging up the fluid introduction passage 94; a seal
member 97 disposed in the fluid introduction passage 94 on one end of the
rod 96 and configured to seal the fluid introduction passage 94; and a
knob section 98 disposed outside of the fluid introduction passage 94 on
the other end of the rod 96.

[0064] Examples of a manner of use or operation of the treatment
instrument 10 for medical use as above-described, procedures for
diagnosis of a paranasal sinus and therapy of sinusitis by use of the
treatment instrument 10 for medical use will be described below.

[0065] First, an operator inserts the introduction section 1 of the
treatment instrument 10 for medical use through a naris, and guides the
flexible tube 2 and the inflation body 8 to a stenosed part S of a
natural ostium of a paranasal sinus PS, while curving the flexible tube
2, as shown in FIG. 5A (Procedure 1).

[0066] Next, the operator operates the first operating section 91 so that
the endoscope 4 protrudes from (extends distally beyond) the flexible
tube 2, and to insert the image sensing unit 42 of the endoscope 4 into
the paranasal sinus PS (Procedure 2). As a result, as shown in FIG. 5B,
the endoscope 4 is curved by the biasing force of the biasing member 41,
and the image sensing unit 42 is directed toward the stenosed part S
side. In this condition, the operator checks the state of the stenosed
part S and the position of the inflation body 8 inside the stenosed part
S, based on image information acquired by the image sensing unit 42
(Procedure 3). Thus, the image sensing unit 42 of the endoscope 4 can be
directed to the stenosed part S, without an operation for curving the
endoscope 4 toward the stenosed part S side by use of a complicated
mechanism. Therefore, the operator can easily observe the state of the
stenosed part S generated at the natural ostium of the paranasal sinus
PS, and can easily observe whether or not the inflation body 8 is
disposed in a position including the stenosed part S.

[0067] When it is confirmed that the inflation body 8 is located in the
stenosed part S, the operator operates the third operating section 93 so
as to introduce a fluid into the inflation body 8, thereby inflating the
inflation body 8, as shown in FIG. 5c (Procedure 4). In this instance,
the image sensing unit 42 of the endoscope 4 is kept facing toward the
stenosed part S side by the biasing force of the biasing member 41;
therefore, the manner in which the inflation body 8 is inflated can be
observed, based on the image information acquired by the image sensing
unit 42.

[0068] Then, when the inflation body 8 is contracted as shown in FIG. 5D,
the operator acquires image information on the stenosed part S after the
inflation of the inflation body 8 (Procedure 5), and determines whether
or not the stenosed part S has been dilated on the basis of the image
information (Procedure 6). In this instance, it can be confirmed by
visual inspection that the stenosed part S has been dilated.

[0069] Thereafter, as shown in FIG. 5E, the operator operates the first
operating section 91 so as to direct the endoscope 4 in a direction
opposite to the biasing direction of the biasing member 41 (in such a
direction that the endoscope 4 becomes rectilinear), thereby directing
the image sensing unit 42 toward a bottom portion of the paranasal sinus
PS. Then, the operator checks the state inside the paranasal sinus PS on
the basis of image information on the inside of the paranasal sinus PS
acquired by the image sensing unit 42 (Procedure 7). In addition, by
repeating the operations of advancing and retracting the first operating
section 91, it is possible to selectively change the angle of a distal
end of the endoscope 4, so that the inside of the paranasal sinus PS can
be observed widely.

[0070] In this instance, when undrained collection D such as mucus or
solid matter formed by solidification of mucus is present inside the
paranasal sinus PS, the operator operates the first operating section 91
so as to draw the endoscope 4 out of the flexible tube 2 and back into
the outer tube 3 (Procedure 8). Thereafter, the operator operates the
second operating section 92 so as to insert and pass the suction tube 5
in the flexible tube 2, as shown in FIG. 5F (Procedure 9), and sucks the
undrained collection D by the suction tube 5 (Procedure 10). In addition,
by introducing a fluid such as physiological saline into the suction tube
5, it is also possible to wash the inside of the paranasal sinus PS with
the fluid. In addition, by introducing a fluid such as physiological
saline into the suction tube 5 by applying pressure (pressurization), it
is also possible to remove the mucosa or tissues from the inside of the
paranasal sinus PS with the pressurized fluid.

[0071] In a case where only observation of the inside of the paranasal
sinus PS is to be conducted, it is possible to only carry out the
above-mentioned Procedures 1, 2 and 7.

[0072] In a case where only dilation of the stenosed part S generated at
the natural ostium of the paranasal sinus PS is to be performed, it is
possible to carry out the above-mentioned Procedures 1 to 4. Further,
with the Procedures 5 and 6 carried out subsequently, it is possible to
visually check whether the stenosed part S has been dilated; thus, it can
be assuredly confirmed that the stenosed part S has been dilated.

[0073] Furthermore, in a case where only therapy of sinusitis is to be
conducted, it suffices to carry out the above-mentioned Procedures 1, 2,
and 7 to 10.

[0074] The medical use treatment instrument disclosed here provides the
following effects.

[0075] Since the flexible tube 2 is disposed at the distal portion of the
outer tube 3 in which the endoscope 4 and the suction tube 5 are
accommodated, the introduction section 1 of the treatment instrument 10
for medical use can be inserted into a living body while curving the
flexible tube 2. In addition, since the connection part between the outer
tube 3 and the flexible tube 2 is decreased in diameter down to the
diameter of the flexible tube 2, the distal portion of the introduction
section 1 can be made small in diameter. Consequently, it is possible to
facilitate insertion of the treatment instrument 10 for medical use into
a living body, while adopting a configuration in which the endoscope 4
and the suction tube 5 can be selectively inserted into and drawn out of
the flexible tube 2.

[0076] In observing the inside of the paranasal sinus PS, the flexible
tube 2 can be deformed to follow the shape of the natural ostium of the
paranasal sinus PS for the purpose of inserting the flexible tube 2 into
the paranasal sinus PS, so that the introduction section 1 of the
treatment instrument 10 for medical use can be easily inserted into the
paranasal sinus PS. Further, since the need to prepare a plurality of
treatment instruments, a hard endoscope or the like as used previously is
eliminated, the number of treatment instruments necessary for curing
sinusitis can be reduced, and the effort and time required for exchange
of the treatment instrument can be reduced.

[0077] Since the endoscope 4 is inserted and passed in the inserted
flexible tube 2, the state inside the paranasal sinus PS can be checked
without any surgical procedure.

[0078] Since the inflation body 8 is inflated after confirming the
position of the inflation body 8 in the stenosed part S at the natural
ostium of the paranasal sinus PS, based on the image information sent
from the endoscope 4 inserted in the paranasal sinus PS, the inflation
body 8 can be inflated at an appropriate position in the stenosed part S.
Therefore, the stenosed part S can be dilated and cured effectively.

[0079] In conveying a fluid into or out of the paranasal sinus PS, the
state inside the paranasal sinus PS can be checked, based on the acquired
image information on the inside of the paranasal sinus PS. This ensures
that an effective therapy can be carried out according to the state
inside the paranasal sinus PS.

[0080] The medical use treatment instrument disclosed here is not limited
to the above-described embodiment, and modifications, improvements and
the like which permit attainment of functions and operations similar to
those associated with the medical use treatment instrument disclosed here
are embraced.

[0081] For instance, while the inflation body 8 has been provided in the
above-described embodiment, the inflation body 8 is indispensable only in
the case of dilating and curing a stenosed part S; thus, the treatment
instrument 10 for medical use may be configured without providing the
inflation body 8.

[0082] While the endoscope 4 has included the biasing member 41 in the
above-described embodiment, the biasing member 41 may be omitted insofar
as the endoscope 4 is so configured that it can be curved by operating
means such as a wire. In addition, the biasing member 41 may be formed
from a material other than nickel-titanium alloy or shape memory alloy,
so long as it can bias the endoscope 4 in a curving direction.

[0083] While the flexible tube 2 has been formed of a metal such as
stainless steel in the above-described embodiment, the flexible tube 2
may be formed from other material such as resins or other metals than the
above-mentioned, insofar as the material is flexible.

[0084] In place of the suction tube 5, other members such as a guide wire
or a forceps may be held inside the second guide tube 7 in an advanceable
and retractable manner.

[0085] While the treatment instrument 10 for medical use has been used for
observation of the inside of a paranasal sinus, dilation of a stenosed
part generated at a natural ostium of the paranasal sinus, or curing of
sinusitis, the treatment instrument 10 for medical use may be used for
observation and/or therapy of other parts in a living body.

[0086] The present invention is applicable not only to a treatment
instrument for medical use which are used for diagnosis and therapy of a
paranasal sinus but also to a treatment instrument for medical use which
are used for other diagnosis or therapy not involving any surgical
procedure.

[0087] The detailed description above describes a treatment instrument for
medical use according to an embodiment disclosed by way of example. The
invention here is not limited, however, to the precise embodiment and
variations described above and illustrated in the drawing figures.
Various changes, modifications and equivalents could be effected by one
skilled in the art without departing from the spirit and scope of the
invention as defined in the appended claims. It is expressly intended
that all such changes, modifications and equivalents which fall within
the scope of the claims are embraced by the claims.

Patent applications by Satoru Suehara, Kanagawa JP

Patent applications in class With tool carried on endoscope or auxillary channel therefore

Patent applications in all subclasses With tool carried on endoscope or auxillary channel therefore